Subclinical AtrIal FibrilLation and StrokE PreveNtion Trial

NCT ID: NCT02004509

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 2054 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-06
• Study Completion Date: 2025-10-31

Brief Summary

Introduction: Patients with atrial fibrillation (AF) have a substantial risk of stroke and systemic embolism. Subclinical AF is often suspected to be the cause of stroke in these patients. The detection of asymptomatic AF episodes is a challenge and the real rate of occurrence of these episodes remains unknown. The rate of stroke is high among patients who have received a pacemaker and this device can detect subclinical episodes of rapid atrial rate, which correlate with electrocardiographically documented AF. The net benefit of anticoagulant treatment is well established in patients with clinical AF but data about anticoagulation in subclinical AF setting is unknown. The aim of this study is to assess the impact of anticoagulant therapy on subclinical AF, directed by cardiac implantable electronic device (CIED) intensive monitoring, on the incidence of stroke and systemic embolism and correlate the AF episodes detected by CIED with thromboembolic events. Methods: This is a prospective, randomized, unicentric, parallel clinical study in patients with atrioventricular pacemaker, defibrillator, or cardiac resynchronization therapy devices in sinus rhythm and CHADS2 score (an index of the risk of stroke in patients with atrial fibrillation, range from 0 to 6) ≥ 2 . Patients will be randomized to the intervention group - intensive monitoring arm (Group I) or control group - routine schedule arm (Group II) in a 1:1 ratio. Time to inclusion will be 24 months and all patients will be followed up for a period of 36 months. Group I, patients will be submitted to device data collection every 2 months, while in Group II, patients will be managed conventionally. Patients from Group I with episodes of subclinical AF will receive anticoagulant therapy, as well as patients with clinical AF of both arms. Device data from Group II patients will not be analyzed until they achieve the primary endpoint. Primary endpoint: stroke or systemic embolism. Secondary endpoints: subclinical AF rate, total mortality, cardiovascular mortality, myocardial infarction, cardiovascular hospitalization, and bleeding rates. Expected outcome: It is expected that anticoagulation therapy of subclinical AF directed by CIED intensive monitoring will reduce the incidence of stroke and systemic embolism comparing to patients with non-diagnosed subclinical AF.

Detailed Description

Patients with atrial fibrillation (AF) have a substantial risk of stroke and systemic embolism. Subclinical AF is often suspected to be the cause of stroke in these patients. The detection of asymptomatic AF episodes is a challenge and the real rate of occurrence of these episodes remains unknown. The rate of stroke is high among patients who have received a pacemaker and this device can detect subclinical episodes of rapid atrial rate, which correlate with electrocardiographically documented AF. The net benefit of anticoagulant treatment is well established in patients with clinical AF but data about anticoagulation for subclinical AF settings is unknown. The aim of this study is to assess the impact of anticoagulant therapy on subclinical AF, directed by cardiac implantable electronic device (CIED) intensive monitoring, on the incidence of stroke and systemic embolism and correlate the AF episodes detected by CIED with thromboembolic events. Methods: This is a prospective, randomized, unicentric, parallel clinical study in patients with an atrioventricular pacemaker, defibrillator, or cardiac resynchronization therapy devices in sinus rhythm and CHADS2 score (an index of the risk of stroke in patients with atrial fibrillation, range from 0 to 6) ≥ 2 . Patients will be randomized to the intervention group - intensive monitoring arm (Group I) or control group - routine schedule arm (Group II) in a 1:1 ratio. Time to inclusion will be 24 months and all patients will be followed up for a period of 36 months. Group I, patients will be submitted to device data collection every 2 months, while in Group II, patients will be managed conventionally. Patients from Group I with episodes of subclinical AF will receive anticoagulant therapy, as well as patients with clinical AF of both arms. Device data from Group II patients will not be analyzed until they achieve the primary endpoint. Primary endpoint: stroke or systemic embolism. Secondary endpoints: subclinical AF rate, total mortality, cardiovascular mortality, myocardial infarction, cardiovascular hospitalization, and bleeding rates. Expected outcome: It is expected that anticoagulation therapy of subclinical AF directed by CIED intensive monitoring will reduce the incidence of stroke and systemic embolism comparing to patients with non-diagnosed subclinical AF.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anticoagulant

Prescription of oral anticoagulation for patients with silent AF (detected by the pacemaker).

Group Type: ACTIVE_COMPARATOR

Anticoagulant

Intervention Type: DRUG

Anticoagulant treatment will be started in case of subclinical atrial fibrillation (\>5,5 hours per day) be diagnosed by cardiac implantable electronic device at intervention group, or clinical atrial fibrillation in both groups.

Control

Patients with silent FA detected only by the pacemaker will no receive oral anticoagulation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Anticoagulant

Anticoagulant treatment will be started in case of subclinical atrial fibrillation (\>5,5 hours per day) be diagnosed by cardiac implantable electronic device at intervention group, or clinical atrial fibrillation in both groups.

Intervention Type: DRUG

Other Intervention Names

Oral Anticoagulant

Eligibility Criteria

Inclusion Criteria

• Age >= 18 years
• CHADS2 score >=2
• Sinus rhythm
• Cardiac Implantable Electronic Device

Exclusion Criteria

• Atrial fibrillation
• Severe heart valve disease
• Anticoagulation therapy
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InCor Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Martino Martinelli Filho

Prof., MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergio F Siqueira, Eng

Role: STUDY_DIRECTOR

Biomedical Eng

Locations

Martino Martinelli Filho

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Martino Martinelli Filho, PhD, MD

Role: CONTACT

martino@incor.usp.br

+551126615515

Sergio F Siqueira, Eng

Role: CONTACT

siqueira@incor.usp.br

+5511973083052

Facility Contacts

Martino MM Martinelli Filho, PHD

Role: primary

martino.filho@incor.usp.br

55 11 2661 5517 ext. 5517

Sergio F Siqueira, Eng

Role: backup

siqueira@incor.usp.br

+5511973083052

Other Identifiers

SILENT

Identifier Type: -

Identifier Source: org_study_id